NEW ORLEANS--(BUSINESS WIRE)--Dec 8, 2009 - Millennium: The
Takeda Oncology Company today reported updated results based on a
planned median three-year follow up of patients from the large,
international Phase III VISTA1 trial. These data were
presented at the 51st Annual Meeting of the American Society of
Hematology (ASH), held December 5-8, 2009 in New Orleans,
Louisiana. These data were the basis for a supplemental new drug
application (sNDA) to the U.S. Food and Drug Administration (FDA)
earlier this year. The FDA has granted priority review status to
that application.

The data showed that patients treated with VELCADE, melphalan
and prednisone (VMP) had significantly longer overall survival (OS)
at three years than those treated with melphalan and prednisone
(MP), a commonly used standard of care (p=0.0008). This translated
into a 35 percent reduction in risk of death (hazard ratio 0.65).
VELCADE based therapy achieved improved OS in both young and
advanced age patients, patients with normal and abnormal renal
function and patients with standard and high-risk cytogenetics. The
survival benefit of VMP persisted despite the use of salvage
therapy with novel agents at relapse. Median survival has not yet
been reached in the VMP arm.

"Prolonging the patient's overall survival is the ultimate goal
in multiple myeloma treatment," said Maria-Victoria Mateos, M.D.,
Ph.D., Hospital Universitario de Salamanca, who presented the
results today. "For the first time in the front-line setting, we
have long-term follow-up data, confirming that VMP results in a
significantly longer overall survival than a standard of care, both
overall and in patients who received subsequent therapy. This
supports the addition of VELCADE to MP in the front line setting,
rather than the use of MP followed by novel agents.”

The VISTA study is the largest Phase III registration trial to
study long-term overall survival in previously untreated multiple
myeloma patients. The VISTA trial enrolled 682 patients with
previously untreated multiple myeloma ineligible for stem cell
transplantation. At the interim analysis that demonstrated the
superiority of VMP over MP, the benefit was seen across all
efficacy endpoints, including overall survival. At this year's
meeting, data with a median follow-up of 36.7 months were presented
by Professor Mateos. In addition, a detailed analysis evaluated the
impact of subsequent therapy on the overall survival results. The
updated results included:

There was a 35 percent reduced
risk of death in the VMP arm, compared with the MP arm (hazard
ratio =0.65, p=0.0008).

The median survival was not
reached in the VMP arm, while the median OS in the MP arm was 43.1
months.

The three-year OS rate was 68.5
percent in the VMP arm, compared with 54 percent in the MP
arm.

The OS advantage in the VMP arm
was maintained despite 69 percent of MP patients receiving
subsequent therapy at relapse.

The median treatment-free
interval (TFI) was 17.6 months in the VMP arm, compared with 8.4
months in the MP arm (p<0.0001).

Retreatment at relapse with
VELCADE based therapies in the VMP arm resulted in a 47 percent
response rate.

VELCADE based therapy achieved
improved OS in both young and advanced age patients, patients with
normal and abnormal renal function and patients with standard and
high-risk cytogenetics.

There were no notable changes in
the safety profiles of VMP and MP from the initial analysis,
presented in 2007.

“These data further solidify the benefit of using VELCADE
as initial therapy, as it provides

a long-term improvement in overall survival,” said Nancy
Simonian, M.D., Chief Medical Officer, Millennium. “These
data also demonstrate that the use of VELCADE upfront preserves
options for subsequent therapy, including VELCADE.”

Patients in the VMP arm of the study received nine 6-week cycles
of VELCADE at 1.3 mg/m2 (days 1, 4, 8, 11, 22, 25, 29
and 32 in cycles 1 through 4 and days 1, 8, 22 and 29 in cycles 5
through 9) with melphalan 9 mg/m2 and prednisone 60
mg/m2 (days 1 through 4 in cycles 1 through 9), or
melphalan plus prednisone, in the same dose and schedule
administered to the patients in the VMP arm. Patients remained on
VMP therapy for a median of 46 weeks (eight cycles) out of the
planned nine cycles versus 39 weeks (seven cycles) with melphalan
and prednisone.

About Multiple Myeloma

Multiple myeloma is the second most common hematologic
malignancy. In the U.S., more than 50,000 individuals have MM and
20,000 new cases are diagnosed each year. Worldwide there are
approximately 74,000 new cases and over 45,000 deaths annually.

About Millennium

Millennium: The Takeda Oncology Company, a leading
biopharmaceutical company based in Cambridge, Mass., markets
VELCADE, a first-in-class proteasome inhibitor, and has a robust
clinical development pipeline of product candidates. Millennium
Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company
Ltd. in May, 2008. The Company's research, development and
commercialization activities are focused in oncology. Additional
information about Millennium is available through its website,
www.millennium.com

About VELCADE

VELCADE is co-developed by Millennium Pharmaceuticals, Inc. and
Ortho Biotech Oncology Research & Development, a unit of
Johnson & Johnson Pharmaceutical Research & Development,
L.L.C., and approved worldwide. Millennium is responsible for
commercialization of VELCADE in the U.S., Janssen-Cilag is
responsible for commercialization in Europe and the rest of the
world. Janssen Pharmaceutical K.K. is responsible for
commercialization in Japan. VELCADE is currently approved in more
than 87 countries worldwide.

Important Safety Information

In the U.S., VELCADE is indicated for the treatment of patients
with multiple myeloma. VELCADE also is indicated for the treatment
of patients with mantle cell lymphoma who have received at least
one prior therapy. VELCADE is contraindicated in patients with
hypersensitivity to bortezomib, boron or mannitol. VELCADE should
be administered under the supervision of a physician experienced in
the use of antineoplastic therapy.

Risks associated with VELCADE therapy include new or worsening
peripheral neuropathy, hypotension throughout therapy, cardiac and
pulmonary disorders, reversible posterior leukoencephalopathy
syndrome, gastrointestinal adverse events, thrombocytopenia,
neutropenia, tumor lysis syndrome and hepatic events. Women of
childbearing potential should avoid becoming pregnant while being
treated with VELCADE. Nursing mothers are advised not to breastfeed
while receiving VELCADE. Cases of severe sensory and motor
peripheral neuropathy have been reported. The long-term outcome of
peripheral neuropathy has not been studied in mantle cell lymphoma.
Acute development or exacerbation of congestive heart failure, and
new onset of decreased left ventricular ejection fraction has been
reported, including reports in patients with no risk factors for
decreased left ventricular ejection fraction. There have been
reports of acute diffuse infiltrative pulmonary disease of unknown
etiology such as pneumonitis, interstitial pneumonia, lung
infiltration and Acute Respiratory Distress Syndrome in patients
receiving VELCADE. Some of these events have been fatal. There have
been reports of Reversible Posterior Leukoencephalopathy Syndrome
(RPLS) in patients receiving VELCADE. RPLS is a rare, reversible,
neurological disorder which can present with seizure, hypertension,
headache, lethargy, confusion, blindness, and other visual and
neurological disturbances. VELCADE is associated with
thrombocytopenia and neutropenia. There have been reports of
gastrointestinal and intracerebral hemorrhage in association with
VELCADE. Transfusions may be considered. Complete blood counts
(CBC) should be frequently monitored during treatment with VELCADE.
Cases of acute liver failure have been reported in patients
receiving multiple concomitant medications and with serious
underlying medical conditions. Patients who are concomitantly
receiving VELCADE and drugs that are inhibitors or inducers of
cytochrome P450 3A4 should be closely monitored for either
toxicities or reduced efficacy. Patients on oral antidiabetic
medication while receiving VELCADE should check blood sugar levels
frequently.

Adverse Reaction Data

Safety data from Phase II and III studies of single-agent
VELCADE 1.3 mg/m2/dose twice weekly for 2 weeks followed
by a 10-day rest period in 1163 patients with previously treated
multiple myeloma (N=1008, not including the Phase III, VELCADE plus
DOXIL® [doxorubicin HCl liposome injection] study)
and previously treated mantle cell lymphoma (N=155) were integrated
and tabulated. In these studies, the safety profile of VELCADE was
similar in patients with multiple myeloma and mantle cell
lymphoma.